A Phase 4 interventional study of Tailored antithrombotic strategy and Conventional antithrombotic strategy in Coronary Stenoses, sponsored by Duk-Woo Park, MD. Completed at 22 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-06-06.
Sponsored by Duk-Woo Park, MD · Phase 4, Interventional, and Treatment
This study evaluates the efficacy and safety of tailored antithrombotic therapy with early (\<6-month post-PCI) intensified (low-dose ticagrelor [120 mg loading, then 60 mg bid maintenance] and aspirin) and late (>6-month post-PCI) deescalated (clopidogrel alone) strategy in patients undergoing high-risk complex PCI as compared with standard Dual Antiplatelet Therapy(aspirin and clopidogrel for 12 months).
Patients must have at least one of any features of complex high-risk anatomic, procedural, or clinical-related factors;
Exclusion Criteria:
Use of strong cytochrome P-450 3A inhibitor or inducers within 2 week of the date of enrollment
: ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir, rifampin/rifampicin, rifabutin, dexamethasone, phenytoin, carbamazepine, phenobarbital
early (\<6-month post-PCI) intensified (low-dose ticagrelor \[120 mg loading, then 60 mg bid maintenance\] and aspirin) and late (\>6-month post-PCI) deescalated (clopidogrel alone) strategy
Drug: Tailored antithrombotic strategy
clopidogrel + aspirin for 12months
Drug: Conventional antithrombotic strategy
Low-dose (60mg) ticagrelor + aspirin for 6months and then clopidogrel alone for 6months
Clopidogrel + aspirin for 12months
Net clinical outcome
a net clinical outcome of all-cause death, myocardial infarction, stroke, stent thrombosis, urgent revascularization or clinically relevant bleeding \[Bleeding Academic Research Consortium (BARC) 2, 3, or 5\] at 12 months after randomisation
Time frame: 1 year
Death
Efficacy outcomes: any, cardiovascular, or non-cardiovascular cause death
Time frame: 1 year
Myocardial infarction
Efficacy outcomes: any, periprocedural, or spontaneous Myocardial infarction
Time frame: 1 year
Stroke
Efficacy outcomes: any, ischemic, or hemorrhagic Stroke
Time frame: 1 year
Stent thrombosis
Efficacy outcomes
Time frame: 1 year
The rate of unplanned urgent repeat revascularization
Efficacy outcomes: any, target-vessel, or non-target-vessel Repeat revascularisation
Time frame: 1 year
Composite of ischemic clinical endpoints (all-cause death, myocardial infarction, stroke, stent thrombosis, or urgent revascularization)
Efficacy outcomes
Time frame: 1 year
Composite of hard clinical endpoints (all-caused death, myocardial infarction, or stroke)
Efficacy outcomes
Time frame: 1 year
BARC major bleeding (type 3 or 5 bleeding)
Safety outcomes: Bleeding Academic Research Consortium
Time frame: 1 year
TIMI major or minor bleeding
Safety outcomes: Thrombolysis In Myocardial Infarction
Time frame: 1 year
GUSTO moderate or severe bleeding
Safety outcomes: Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries
Time frame: 1 year
ISTH major bleeding
Safety outcomes: International Society of Thrombosis and Hemostasis; PCI, percutaneous coronary intervention
Time frame: 1 year
Any major or minor bleeding
Safety outcomes
Time frame: 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Duk-Woo Park, MD